The present disclosure relates to bowel irrigation devices, more particularly to a transanal irrigation kit for instilling irrigation fluid into the rectal cavity while also simultaneously stimulating the reflex defecatory response.
Anal irrigation kits and methods to stimulate the rectal reflex reaction are well known for use by individuals afflicted with neurogenic bowel dysfunction. Neurogenic bowel dysfunction is a disruption of the normal function of the bowel commonly associated with persons suffering from spinal cord injuries, amyotrophic lateral sclerosis, spina bifida, multiple sclerosis, and diabetes mellitus.
In the most common form of this dysfunction, the bowel will respond reflexively to certain stimuli, but the person cannot empty the bowel with cognitive volition. One method for emptying the bowel for these patients is the general approach referred to as bowel irrigation. In this approach a fairly large amount of liquid is instilled into the bowel, filling the lower bowel. Traditionally this is done by a gravity feed of the liquid, which is a relatively slow liquid instillation. This results in the emptying of the bowel. It is, however, not known to what extent the reflex bowel reaction is involved in bowel emptying as a result of the irrigation. It is thought that this irrigation technique works by mobilizing the bowel contents in the liquid.
This technique typically requires more than 500 mL and up to 2000 mL of liquid and usually takes a considerable amount of time, up to 30 minutes. The fluid path into the rectum is typically provided by a flow manifold having a cone-shaped end, which flares toward the distal direction, such that the narrow end of the cone is inserted into the rectum. The reverse flared end keeps the user from inserting the rigid tubing end too far into the rectum. The cone-shaped end of the flow manifold is typically fairly rigid to facilitate insertion, and so its use presents at least some risk of anal and rectal trauma.
Many of these irrigation systems require the user to hold the flow manifold in place during instillation of the liquid. To improve upon the inconvenience of having to hold the manifold in place during the irrigation process, some irrigation systems including a retention cuff or a balloon to retain the flow manifold in the rectum have been developed. However, the retention cuff or balloon can be overinflated, and increase the risk of rectal trauma. Further, there have been reports of the balloons rupturing due to over inflation, resulting in an alarming noise and destruction of the product. Furthermore, the retention cuff or the balloon inflation step takes time, and often adds complexity to the irrigation systems.
Another disadvantage of current bowel irrigation kits is their size. They are generally large, unwieldy, and take up a lot of storage space. This makes them inconvenient for travel and indiscreet in the home. An important factor in their large size is that the liquid reservoir in these current bowel irrigation kits is designed to hold two liters or more in irrigation liquid. This in turn requires the reservoir to be able to rest on the floor, or to be hung in a location remote from the point of use, which in rum requires a fairly long tubing set to conduct the liquid from the reservoir to the point of use.
Another general and commonly used approach for emptying the bowel is digital stimulation. This approach involves inserting a finger or a dilstick into the rectum, pressing on the rectal wall with the finger or the dilstick, and rotating the finger or the dilstick in a circular manner to stimulate the bowel reflex. This stimulation of the rectal wall causes a reflex reaction that is a defecatory response of the lower bowel. The reflex reaction includes the initiation of peristaltic waves beginning at the splenic flexure, which is the start of the descending colon, down through the sigmoid, and into the rectum. This response also includes relaxation of the internal anal sphincter, which enables emptying of the lower bowel.
The details of digital stimulation required for a robust reflex response are known only through the trial and error of experience. It seems that multiple stimulation episodes and rotation of the finger around the rectal wall are both important for a good bowel response. The digital stimulation does not require liquid instillation, thus results in less bowel output to manage, and bowel evacuation can proceed somewhat faster than gravity fed irrigation. However, digital stimulation does require inserting a finger or a dilstick into the rectum, which can present a significant risk of trauma for the anal canal and for the rectum.
Accordingly, there is a need for an improved transanal irrigation kit that provides a lower risk of trauma and a more efficient bowel emptying process, which can be easily manipulated by the user.